QPZ — Contact Cooling For Skin Lesion Pain Relief Class II
FDA product code QPZ covers "Contact Cooling For Skin Lesion Pain Relief", a Class II medical device regulated under 21 CFR 878.4340. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QPZ
- Device Class
- Class II
- Regulation Number
- 878.4340
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.